ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE- benzoyl peroxide cream 
ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ZO ® Skin Health Acne Control 10% Benzoyl Peroxide

National Drug Code 42851-087-60

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Uses

For the treatment of acne.

Warnings

For external use only.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

  • irritation becomes severe

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Sensitivity Test for a New User.

Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

Other Information

Inactive Ingredients

Aqua/Water/Eau, Aspalathus Linearis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-40 Stearate, PEG-8 Laurate, Phenoxyethanol, Pinus Strobus Bark Extract, Polyglyceryl-6 Isostearate, Propanediol, Propylene Glycol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-087-60

ACNE CONTROL
10% Benzoyl Peroxide

60 mL / 2 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-087
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PINUS STROBUS BARK (UNII: 8PJ4761097)  
POLYGLYCERYL-6 ISOSTEARATE (UNII: 5VKGO1O03G)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-087-601 in 1 CARTON05/25/2023
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/25/2023
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 5/2023
Document Id: fcf13405-2f1a-a703-e053-6294a90a6947
Set id: 252b2352-a457-4009-a62b-0ec98f018b2e
Version: 5
Effective Time: 20230530
 
ZO Skin Health, Inc.